A Phase 3 Study in Participants With Moderate to Severe Psoriasis (UNCOVER-2)

Summary

This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to etanercept and placebo in participants with moderate to severe chronic plaque psoriasis.

Timeline

Start

2012-05-18

Primary completion

2014-03-25

Completion

2019-06-18

Publications

• Egeberg A, Hawkes JE, Somani N, Burge R, See K, Gallo G, McKean-Matthews M, Gooderham M, Han G, Armstrong A. Sustained Improvements in Clinical and Patient-Reported Outcomes and Quality of Life Through 5 Years Among Ixekizumab-Treated Patients with Complete Clearance of Scalp Psoriasis by Week 60. Dermatol Ther (Heidelb). 2024 Apr;14(4):1007-1018. doi: 10.1007/s13555-024-01147-7. Epub 2024 Apr 22.
• Armstrong A, Gonzalez-Cantero A, Khattri S, Muzy G, Malatestinic WN, Lampropoulou A, Feely M, See SK, Mert C, Blauvelt A. Comparing Achievement of National Psoriasis Foundation Treatment Targets among Patients with Plaque Psoriasis Treated with Ixekizumab versus Other Biologics in Clinical and Real-World Studies. Dermatol Ther (Heidelb). 2024 Apr;14(4):933-952. doi: 10.1007/s13555-024-01136-w. Epub 2024 Mar 23.
• Kirkham BW, Egeberg A, Behrens F, Pinter A, Merola JF, Holzkamper T, Gallo G, Ng KJ, Bolce R, Schuster C, Nash P, Puig L. A Comprehensive Review of Ixekizumab Efficacy in Nail Psoriasis from Clinical Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis. Rheumatol Ther. 2023 Oct;10(5):1127-1146. doi: 10.1007/s40744-023-00553-1. Epub 2023 Jul 3.
• Elewski BE, Blauvelt A, Gallo G, Wolf E, McKean-Matthews M, Burge R, Merola JF, Gottlieb AB, Guenther LC. Simultaneous Nail and Skin Clearance in Ixekizumab Head-to-Head Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis. Dermatol Ther (Heidelb). 2022 Apr;12(4):911-920. doi: 10.1007/s13555-022-00704-2. Epub 2022 Mar 13.
• Rich P, Goldblum O, Disch D, Lin CY, Merola JF, Elewski B. Nail Psoriasis Does Not Affect Skin Response to Ixekizumab in Patients With Moderate-To-Severe Psoriasis. J Drugs Dermatol. 2020 Aug 1;19(8):741-746. doi: 10.36849/JDD.2020.5116.
• Leonardi C, Reich K, Foley P, Torii H, Gerdes S, Guenther L, Gooderham M, Ferris LK, Griffiths CEM, ElMaraghy H, Crane H, Patel H, Burge R, Gallo G, Shrom D, Leung A, Lin CY, Papp K. Efficacy and Safety of Ixekizumab Through 5 Years in Moderate-to-Severe Psoriasis: Long-Term Results from the UNCOVER-1 and UNCOVER-2 Phase-3 Randomized Controlled Trials. Dermatol Ther (Heidelb). 2020 Jun;10(3):431-447. doi: 10.1007/s13555-020-00367-x. Epub 2020 Mar 21.
• Yosipovitch G, Reich A, Steinhoff M, Beselin A, Kent T, Dossenbach M, Berggren L, Henneges C, Luger T. Impact of Ixekizumab Treatment on Itch and Psoriasis Area and Severity Index in Patients with Moderate-to-Severe Plaque Psoriasis: An Integrated Analysis of Two Phase III Randomized Studies. Dermatol Ther (Heidelb). 2018 Dec;8(4):621-637. doi: 10.1007/s13555-018-0267-9. Epub 2018 Nov 21.
• Blauvelt A, Papp KA, Griffiths CEM, Puig L, Weisman J, Dutronc Y, Kerr LF, Ilo D, Mallbris L, Augustin M. Efficacy and Safety of Switching to Ixekizumab in Etanercept Non-Responders: A Subanalysis from Two Phase III Randomized Clinical Trials in Moderate-to-Severe Plaque Psoriasis (UNCOVER-2 and -3). Am J Clin Dermatol. 2017 Apr;18(2):273-280. doi: 10.1007/s40257-016-0246-9.
• Gordon KB, Blauvelt A, Papp KA, Langley RG, Luger T, Ohtsuki M, Reich K, Amato D, Ball SG, Braun DK, Cameron GS, Erickson J, Konrad RJ, Muram TM, Nickoloff BJ, Osuntokun OO, Secrest RJ, Zhao F, Mallbris L, Leonardi CL; UNCOVER-1 Study Group; UNCOVER-2 Study Group; UNCOVER-3 Study Group. Phase 3 Trials of Ixekizumab in Moderate-to-Severe Plaque Psoriasis. N Engl J Med. 2016 Jul 28;375(4):345-56. doi: 10.1056/NEJMoa1512711. Epub 2016 Jun 8.
• Armstrong AW, Lynde CW, McBride SR, Stahle M, Edson-Heredia E, Zhu B, Amato D, Nikai E, Yang FE, Gordon KB. Effect of Ixekizumab Treatment on Work Productivity for Patients With Moderate-to-Severe Plaque Psoriasis: Analysis of Results From 3 Randomized Phase 3 Clinical Trials. JAMA Dermatol. 2016 Jun 1;152(6):661-9. doi: 10.1001/jamadermatol.2016.0269.
• Griffiths CE, Reich K, Lebwohl M, van de Kerkhof P, Paul C, Menter A, Cameron GS, Erickson J, Zhang L, Secrest RJ, Ball S, Braun DK, Osuntokun OO, Heffernan MP, Nickoloff BJ, Papp K; UNCOVER-2 and UNCOVER-3 investigators. Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from two phase 3 randomised trials. Lancet. 2015 Aug 8;386(9993):541-51. doi: 10.1016/S0140-6736(15)60125-8. Epub 2015 Jun 10.

Drugs

Indications